RBR-4ws3sb5招募中4 期
Evaluation of the Effects of Vitamins B on Adult Research Participants - DUBLIN Dozemast sUBLINgual
oema - Instituto de Pesquisa Clínica e Consultores SS Ltda0 个研究点开始时间: 2024年4月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18Y 至 65Y（—）
入选标准
- •Participants of both sexes; aged between 18 and 65 years; who have the capacity to understand and agree to participate in the study, indicating by signing the Free and Informed Consent Form approved by the Research Ethics Committee System; and agreeing to comply with the planned study procedures and to attend the visits; will be included in the study must be vitamin B12 deficient (serum cobalamin dosage < 300 pg/mL), good health, determined by the absence of significant findings in medical history, physical examination, laboratory tests (biochemistry, hematology, and urinalysis), measurement of vital signs, and electrocardiogram results; participants who do not have reproductive potential should be checked for their current condition, such as: postmenopausal women (defined as 12 months or more of amenorrhea), hysterectomized women, oophorectomized women (bilateral) and/or have undergone tubal ligation (tubal ligation); the female participants must have childbearing potential who present a negative pregnancy test result on the day of administration of the first dose of the drugs of the study, as well as throughout the clinical trial; and agree on the use of safe contraception
排除标准
- •Participants who have any clinical condition that, at the discretion of the investigator, may compromise participation in the study, and/or have difficulty swallowing solid medications; have a diagnosis of pernicious anemia or documented or suspected hemoglobinopathies; have a diagnosis of gastrointestinal disease that compromises the absorption of vitamin B12 administered orally (atrophic gastritis or Crohn's disease); have undergone bariatric surgery (partial or complete gastrectomy, or gastric reduction surgery); have undergone ileal resection or pancreaticopancreatical; have a documented or suspected diagnosis of pancreatic disease; or have undergone pancreatectomy; have undergone oral treatment with vitamin B12 (mecobalamin, hydroxycobalamin or cyanocobalamin) and/or multivitamins containing vitamin B12 in the last 30 days; or have been treated with injectable formulations containing vitamin B12 in the last 3 months; have chronic liver disease (documented or suspected) or current laboratory abnormality of liver enzymes; have chronic kidney injury requiring dialysis; have a history of myeloproliferative diseases or other neoplastic/metastatic diseases in the last 5 years; use levodopa, phenobarbital, phenytoin, primidone, pyrimethamine, valproic acid, hydantoin, aminosalicylates, aminoglycosides, colchicine, potassium in extended-release formulation, mesalazine, ascorbic acid, antibiotics, nitrates, fluorouracil, chloramphenicol, proton inhibitors, metformin, and biotin (vitamin B7); have a history of alcoholism (average alcohol intake of more than 3 drinks of alcoholic beverages in one day or more than 7 drinks of alcoholic beverages per week, for women, and more than 4 drinks of alcoholic beverages in one day or more than 14 drinks of alcoholic beverages per week, for men); or having ingested alcoholic beverages in the last week prior to the start of treatment; have a folate deficiency and/or having an iron deficiency; if the participant is pregnant, breastfeeding and/or intends to become pregnant during the study period; have hypersensitivity or contraindication to use of study drugs or chemically related compounds; have participated in clinical studies in the past twelve (12) months, unless there may be direct benefit to the research participant, at the discretion of the investigator
研究者
相似试验
尚未招募
2 期
Protective effect of B Vitamin on the prevention of Diabetic Retinopathy.CTRI/2023/01/049218akshmi Kanta Mondal
招募中
不适用
Evaluation of the effect of vitamin B supplementation on pain caused by implant surgeryIRCT20180630040290N5Tabriz University of Medical Sciences46
招募中
不适用
The effect of Vitamin B-Complex on MigraineMigraine with auraIRCT20131012014988N6Tabriz University of Medical Sciences90
招募中
3 期
Evaluation of the effect of vitamin B complex on nocturnal enuresisIRCT20201028049172N1Arak University of Medical Sciences70
尚未招募
2 期
Fenomin and Diabetic foot ulcerPACTR202106542254817fv Supplement Ltd200